Maternal And Infant Antipsychotic Study

NCT06049953 | Recruiting FDA Drug

• 2 other identifiers: STUDY 23-00239R01HD111117-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about maternal psychiatric course and infant development in pregnant individuals with severe mental illness, comparing those treated with antipsychotics to those treated with other medications or without medication. The main questions it aims to answer are:

• complete a psychiatric interview and questionnaires while pregnant;
• donate blood from the mother and from the umbilical cord at delivery
• have their babies participate in infant behavior evaluations and an EEG procedure. Researchers will compare these outcomes among individuals who were treated either with antipsychotic medication, with psychotropic medications of other classes, and with no medication, to see if psychiatric benefits for the mother and health outcomes for mother and child differ among these three types of treatment.

Conditions

Antipsychotics; Pregnancy

Keywords

antipsychotic; pregnancy; severe mental illness; neonatal adaptation syndrome; neurodevelopment

Outcome Measures

Primary Outcomes (3)

• Mini-International Neuropsychiatric Interview

  In the DSM-5 Mini-International Neuropsychiatric Interview (M.I.N.I.) researchers will conduct modules for major depressive episode, (hypo)manic episode, and psychotic disorders. A clinical structured interview with very precise questions about psychological problems will require a 'yes' or 'no' answer. The M.I.N.I. is divided into modules identified by letters, each corresponding to a diagnostic category. At the beginning of each diagnostic module (except for psychotic disorders module), screening questions(s) corresponding to the main criteria of the disorder are presented in a gray box. At the end of each module, diagnostic box(es) permit the clinician to indicate whether diagnostic criteria are met.

  through study completion, an average of 6 months postpartum

• Finnegan Neonatal Abstinence Scoring System

  Symptoms of poor neonatal adaptation, as assessed by Finnegan scale at 24 hours of life. Finnegan Neonatal Abstinence Scoring System (NAS) is an observer-rated scale documenting signs of neonatal adaptation. The individual NAS symptoms are weighted (numerically scoring 1-5) depending on the symptom, and the severity of the symptom expressed. The total score ranges from 0 to 43. Infants scoring an 8 or greater are recommended to receive pharmacologic therapy.

  24 hours postnatal

• Ratio of auditory evoked potentials as measured by EEG

  Electrical activity of brain cells in response to a sound stimulus, measured noninvasively on the outside of the scalp by electroencephalography

  6 months postnatal

Secondary Outcomes (17)

• Maternal weight gain

  through delivery, approximately 40 weeks post conception

• Oral glucose tolerance test score

  at 24 weeks

• Fetal body size

  at 20 weeks

• Fetal weight

  at 20 weeks

• Fetal head circumference

  at 20 weeks

Study Arms (3)

Antipsychotic medication

Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are treated with any of the following medications during pregnancy: Quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, lurasidone, haloperidol, or any other medication in the first- or second-generation antipsychotic class. All orally administered, with dosages titrated to clinical effect by the participant's primary psychiatrist.

Drug: Antipsychotics

Non-antipsychotic medication

Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are treated with any psychotropic medications during pregnancy other than those listed.

Drug: Non-antipsychotic medication

No medication

Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are not treated with any psychotropic medications during pregnancy.

Other: No Medication

Interventions

Antipsychotics DRUG

Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.

Antipsychotic medication

Non-antipsychotic medication DRUG

Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and/or insomnia.

Also known as: Antidepressants, Benzodiazepines

Non-antipsychotic medication

No Medication OTHER

Non-psychotropic medications

No medication

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with severe mental illness as defined in Eligibility Criteria

You may qualify if:

• Pregnant
• Severe mental illness, including:
• Psychotic disorder (affective and nonaffective)
• Bipolar disorder
• History of psychiatric hospitalization, regardless of diagnosis
• Able to complete study interviews and measures in English, Dutch, or Spanish

You may not qualify if:

• Active substance use disorder in pregnancy
• Insufficiently high-functioning to provide full informed consent and/or participate in study procedures

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Erasmus Medical Center: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Paired whole blood and plasma samples obtained from the mother and from the umbilical cord at delivery will be stored.

MeSH Terms

Conditions

Mental Disorders

Interventions

Antipsychotic Agents; Antidepressive Agents; Benzodiazepines

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thalia Robakis, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Floriana Milazzo, MPH

CONTACT

(212) 659-1326; floriana.milazzo@mssm.edu

Veerle Bergink, MD, PhD

CONTACT

2126591326; veerle.bergink@mssm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 22, 2023
• Study Start: September 29, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)